Evaluation And Identification Of Subvisible Particulate Matter In Injections

By Mary Tan

The presence of particulate matter (PM) in parenteral drug products is a well-known challenge for pharmaceutical companies due to the potential quality and safety risks involved. In biotherapeutics, critical attributes related to efficacy, potency, clinical safety, and immunogenicity can be affected by PM.^1-3

PM is defined as extraneous mobile undissolved particles (excluding gas bubbles) that are unintentionally present in solutions.⁴

Several USP chapters describe the measurement of PM, namely:

• <787> Subvisible Particulate Matter in Therapeutic Protein Injections
• <788> Particulate Matter in Injections
• <789> Particulate Matter in Ophthalmic Solutions
• <790> Visible Particulates in Injections

In this article, the scopes of <787> and <788> will be discussed since both chapters address injections and have the same regulatory requirements according to their nominal volumes for subvisible PM.